3-day vs. 7-day Faropenem Regimen for Treatment of Acute Uncomplicated Cystitis
Introduction
The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum b-lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern. Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria. It is stable against several b-lactamases.
Aim
To evaluate the efficacy of faropenem against cystitis and to determine the optimal faropenem treatment duration.
Patient Profile
- Women aged ≥20 years, with any cystitis symptoms, such as micturition pain, urinary frequency, urge to urinate, or lower abdominal pain with pyuria and bacteriuria
- Target bacteria: Staphylococcus spp., Enterococcus faecalis, Streptococcus agalactiae and Enterobacteriaceae
Methods
- Multicentre, randomized, open-label, controlled study comparing 3- and 7-day administration regimens of faropenem
- Treatment: 200 mg faropenem sodium tablet administered three times daily (600 mg/day) for 3 or 7 days
Study endpoints
- Primary: Microbiological outcome 5–9 days after treatment completion
- Second endpoint: Clinical outcome 5–9 days or 4–6 weeks after treatment
Results
- E. coli accounted for 73.9% of the isolated bacterial strains. Highest faropenem MIC was 2 mg/L and this strain was eradicated after 7 days of treatment
- Clinical efficacies 5-9 days after treatment in 3-days and 7-days groups: 76.7% vs. 80.2% (P=0.695)
- Clinical efficacies 4-6 weeks after treatment completion in 3-days and 7-days groups: 46.2% vs. 50.0% (P=0.717)
Table 1: Comparison of Study Endpoints
|
|
Microbiological evaluation |
Clinical evaluation |
|
5-9 days after treatment |
|
|
|
3-day treatment group |
Eradication 58.9% |
Cure 76.7% |
|
|
Persistence 20.5% |
Failure 16.4% |
|
|
Replaced 8.2% |
|
|
7-day treatment group |
Eradication 66.7% |
Cure 80.2% |
|
|
Persistence 6.2% |
Failure 6.2% |
|
|
Replaced 7.4% |
|
|
4-6 weeks after treatment |
|
|
|
3-day treatment group |
Eradication 40.4% |
Cure 46.2% |
|
|
Replaced 5.8% |
Failure 5.8% |
|
|
Reinfection 3.8% |
|
|
7-day treatment group |
Eradication 38.6% |
Cure 50.0% |
|
|
Replaced 5.7% |
Failure 1.4% |
|
|
Reinfection 4.3% |
|
Safety: Adverse events due to faropenem were reported in 9.5% of participants and most common adverse event was diarrhoea.
Conclusion
- Optimal regimen of faropenem for cystitis was determined to be 200 mg three times daily for 7 days
- E. coli strains resistant to fluoroquinolones or cephalosporins showed high susceptibility to faropenem
Reference
J Antimicrob Chemother 2014; 69: 1675–1680
Introduction
The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum b-lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern. Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria. It is stable against several b-lactamases.
Aim
To evaluate the efficacy of faropenem against cystitis and to determine the optimal faropenem treatment duration.
Patient Profile
-
Women aged ≥20 years, with any cystitis symptoms, such as micturition pain, urinary frequency, urge to urinate, or lower abdominal pain with pyuria and bacteriuria
-
Target bacteria: Staphylococcus spp., Enterococcus faecalis, Streptococcus agalactiae and Enterobacteriaceae
Methods
-
Multicentre, randomized, open-label, controlled study comparing 3- and 7-day administration regimens of faropenem
-
Treatment: 200 mg faropenem sodium tablet administered three times daily (600 mg/day) for 3 or 7 days
Study endpoints
-
Primary: Microbiological outcome 5–9 days after treatment completion
-
Second endpoint: Clinical outcome 5–9 days or 4–6 weeks after treatment
Results
-
E. coli accounted for 73.9% of the isolated bacterial strains. Highest faropenem MIC was 2 mg/L and this strain was eradicated after 7 days of treatment
-
Clinical efficacies 5-9 days after treatment in 3-days and 7-days groups: 76.7% vs. 80.2% (P=0.695)
-
Clinical efficacies 4-6 weeks after treatment completion in 3-days and 7-days groups: 46.2% vs. 50.0% (P=0.717)
Table 1: Comparison of Study Endpoints
|
|
Microbiological evaluation |
Clinical evaluation |
|
5-9 days after treatment |
|
|
|
3-day treatment group |
Eradication 58.9% |
Cure 76.7% |
|
|
Persistence 20.5% |
Failure 16.4% |
|
|
Replaced 8.2% |
|
|
7-day treatment group |
Eradication 66.7% |
Cure 80.2% |
|
|
Persistence 6.2% |
Failure 6.2% |
|
|
Replaced 7.4% |
|
|
4-6 weeks after treatment |
|
|
|
3-day treatment group |
Eradication 40.4% |
Cure 46.2% |
|
|
Replaced 5.8% |
Failure 5.8% |
|
|
Reinfection 3.8% |
|
|
7-day treatment group |
Eradication 38.6% |
Cure 50.0% |
|
|
Replaced 5.7% |
Failure 1.4% |
|
|
Reinfection 4.3% |
|
Safety: Adverse events due to faropenem were reported in 9.5% of participants and most common adverse event was diarrhoea.
Conclusion
-
Optimal regimen of faropenem for cystitis was determined to be 200 mg three times daily for 7 days
-
E. coli strains resistant to fluoroquinolones or cephalosporins showed high susceptibility to faropenem
Reference
J Antimicrob Chemother 2014; 69: 1675–1680






